BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE A-T SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2261001 · Received September 23, 2011

    Report

    Report Number
    2024168-2011-06523
    Event Type
    Injury
    Date Received
    September 23, 2011
    Date of Event
    January 1, 2003
    Report Date
    September 2, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THE DEVICES WERE DISCARDED. THE RETURN OF THE DEVICES MAY HAVE ASSISTED THE INVESTIGATION OF THE REPORTED EVENTS. NO INFORMATION WAS PROVIDED REGARDING USER TECHNIQUE/ANATOMICAL CONDITIONS TO EVALUATE DURING THIS INVESTIGATION, WHICH MAY HAVE AFFECTED THE DEVICE PERFORMANCE. DURING MANUFACTURING, ALL DEVICES ARE VISUALLY INSPECTED AND A SAMPLING OF FINISHED DEVICES IS DESTRUCTIVELY TESTED TO VERIFY THE FUNCTIONALITY OF THE DEVICE. IN ADDITION, A QUALITY CONTROL AUDIT INSPECTION IS PERFORMED TO VERIFY PRODUCT QUALITY. THIS REPORT CONCERNS A 5 YEAR STUDY DURING WHICH ABBOTT VASCULAR CLOSURE DEVICES AND ANOTHER MANUFACTURER CLOSURE DEVICE WERE USED. IT IS NOT INDICATED WHICH PATIENT OUTCOMES WERE EXPERIENCED DURING THE USE OF ABBOTT DEVICES. FURTHERMORE, A SPECIFIC MODE OF FAILURE OF THE DEVICES WAS NOT REPORTED AND IT IS NOT POSSIBLE TO ESTABLISH A CORRELATION BETWEEN USER TECHNIQUE, PATIENT ANATOMICAL CONDITIONS AND THE REPORTED EVENTS DUE TO A LACK OF INCIDENT DETAILS. THEREFORE, A CONCLUSIVE CAUSE FOR THE REPORTED EVENTS COULD NOT BE DETERMINED. A REVIEW OF THE DEVICE LOT HISTORY RECORD AND A QUERY OF THE COMPLAINT HANDLING DATABASE COULD NOT BE PERFORMED BECAUSE THE LOT NUMBER OF THE DEVICES WERE NOT REPORTED AND THE DEVICES WERE DISCARDED. BASED ON THE REVIEW OF THE REPORTED INFORMATION AND MANUFACTURING TESTING/INSPECTION CRITERIA FOR THIS DEVICE, A PRODUCT QUALITY DEFICIENCY WAS NOT NOTED.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE MEAN AGE WAS (B)(6) YEARS. PTS 358 MALES AND 106 FEMALES. (DATE OF EVENT): THE PROCEDURES WERE PERFORMED BETWEEN (B)(6) 2003 AND (B)(6) 2008. THE DATE FOR (B)(6) 2003 IS BEING USED AS THE BEST ESTIMATED DATE OF OCCURRENCE. THIS STUDY DOES NOT MAKE A DIRECT CORRELATION BETWEEN THE ADVERSE OUTCOMES AND THE VESSEL CLOSURE DEVICES = STARCLOSE AND PERCLOSE AT (ABBOTT DEVICES) AND ANGIOSEAL (ST. JUDE). PLACEMENT OF EITHER CLOSURE DEVICE WAS PERFORMED IN THE CARDIAC CATHETERIZATION LABORATORY IMMEDIATELY AT THE END OF THE PROCEDURE AND FOLLOWING THE MANUFACTURERS GUIDELINES. ALL PATIENTS WERE EVALUATED AFTER DISCHARGE TO RULE OUT LATE VASCULAR COMPLICATIONS. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED. CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES (CONTINUED): SHEATH: 6FR, 7 FR. OTHER: ASPIRIN, ABCIXIMAB, HEPARIN, CLOPIDOGREL. THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS NOT IDENTIFIED; THEREFORE, A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH RELEVANT INFORMATION. THE STARCLOSE DEVICES ARE BEING FILED UNDER A SEPARATE MEDWATCH MFR NUMBER.

    Description of Event or Problem · 1

    THE FOLLOWING EVENTS WERE NOTED DURING A SINGLE-CENTER PROSPECTIVE STUDY REVIEW (FROM (B)(6) 2003 AND (B)(6) 2008). THE HOSPITAL DATABASE WAS SEARCHED AND THE OUTCOMES OF 558 PATIENTS WERE STUDIED TO EVALUATE THE SAFETY AND EFFICACY OF VCDS (VESSEL CLOSURE DEVICES) COMPARED WITH MANUAL COMPRESSION IN THE SETTING OF TRANSFEMORAL PCI (PERCUTANEOUS CORONARY INTERVENTION) PERFORMED AT THE ACUTE PHASE OF STEMI (ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION). THE METHOD OF CLOSURE OF THE COMMON FEMORAL ARTERY WAS CHOSEN INDIVIDUALLY BY THE INTERVENTIONALIST. OF THE TOTAL STUDY POPULATION, OF 558 PATIENTS: 464 RECEIVED A VCD AND 94 PATIENTS UNDERWENT MANUAL COMPRESSION. CHOICE OF THE TYPE OF DEVICE WAS LEFT TO THE OPERATOR PREFERENCE BETWEEN 3 AVAILABLE DEVICES: ANGIOSEAL (276 CASES), PERCLOSE AT (131 CASES) AND STARCLOSE (57 CASES). MAJOR VASCULAR COMPLICATIONS (MVC) WERE 20 IN THE VCD GROUP: DROP IN HEMOGLOBIN EQUAL OR GREATER THAN 3 G/DL: 19 PATIENTS, BLOOD TRANSFUSION: 11, INTERVENTIONAL/SURGICAL REPAIR: 3, RETROPERITONEAL BLEEDING: 4, PSEUDOANEURYSM: 1, ARTERIOVENOUS FISTULA: 4, HEMATOMA: 61, OOZING: 26 AND INFECTION: 1. THE RISK OF MVC WAS SIGNIFICANTLY LOWER WITH VCDS COMPARED WITH MANUAL COMPRESSION (4.3% VS. 9.6%). MINOR VASCULAR COMPLICATIONS OCCURRED IN 78 PATIENTS. MEAN HOSPITAL STAY FOR PATIENTS WITHOUT VASCULAR COMPLICATIONS WAS 7.1 +/- 6.7 DAYS IN THE VCD GROUP.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL MEDWATCH REPORT ADDITIONAL INFORMATION RECEIVED INDICATES: THE PHYSICIAN WAS NOT ABLE TO PROVIDE A DIRECT CORRELATION BETWEEN ANY OF THE ADVERSE EVENTS AND THE VESSEL CLOSURE DEVICE USED IN EACH CASE. HE STATED THAT THE PURPOSE OF THE STUDY WAS TO DEMONSTRATE THAT THE USE OF CLOSURE DEVICES IS A MORE EFFECTIVE METHOD THAN MANUAL COMPRESSION TO ACHIEVE HEMOSTASIS; AND THE RESULTS OBTAINED SUPPORT THAT STATEMENT. IT WAS ALSO INDICATED BY THE PHYSICIAN THAT ALL THE PHYSICIANS INVOLVED IN THE PROCEDURES ARE TRAINED IN THE USE OF THE PERCLOSE AT AND STARCLOSE DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERCLOSE A-T SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention